Business, energy, technology, markets and global industry news from Business News Today

U.S. Food and Drug Administration

Pharma & Biotech

Bezisterim Phase 2 results highlight potential new treatment approach for Parkinson’s disease symptoms

BioVie's bezisterim shows promising Phase 2 Parkinson's results in patients with elevated inflammation. Explore the findings and Phase 3 outlook.

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Pharma & Biotech

Rapport Therapeutics’ RAP-219 delivers statistically significant bipolar mania improvements in Phase 2 trial

Rapport Therapeutics' RAP-219 meets Phase 2 bipolar mania endpoints. Explore its clinical results, safety findings and planned Phase 3 trials.

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Pharma & Biotech

EB613 oral osteoporosis treatment gains momentum as Entera Bio outlines 900-patient Phase 3 trial

Entera Bio reports stronger EB613 bone density gains in Phase 2 osteoporosis analysis. Explore the results and upcoming Phase 3 trial plans.

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Pharma & Biotech

Can Alpha Cognition’s new manufacturing process strengthen ZUNVEYL market protection?

Alpha Cognition publishes a ZUNVEYL manufacturing patent application as sales grow, targeting process protection through 2045.

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Pharma & Biotech

Can Zydus saroglitazar compete with Iqirvo and Livdelzi in the US PBC market?

Zydus saroglitazar shows 60.7% US biochemical response in PBC as its November 27 FDA decision approaches. Examine the Phase 3 evidence.

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Medical Devices & Diagnostics

An implant for severe asthma? Spiro Medical begins testing spinal nerve stimulation beyond drugs

Spiro Medical implants its first PULSAR asthma patient as a 30-person study tests spinal nerve stimulation for severe, uncontrolled asthma.

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Pharma & Biotech

Keenova’s TERLIVAZ shows kidney response in transplant-ineligible patients as new CONFIRM analysis emerges

Keenova's TERLIVAZ analysis examines kidney recovery in transplant-ineligible HRS-AKI patients as respiratory safety and survival remain key concerns.

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Pharma & Biotech

Catalent is entering unit-dose OTC gels with Mantra. Can medicine in a pouch challenge pills?

Catalent will manufacture Mantra's single-serve OTC gels for sleep, pain and menstrual relief. See what the deal means for drug delivery and supply.

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Pharma & Biotech

Bristol Myers Squibb’s $4.1bn RayzeBio acquisition delivers clinical milestone

Bristol Myers Squibb's RYZ101 meets its Phase 3 endpoint after lutetium-177 treatment, advancing alpha radiopharmaceutical development.

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Medical Devices & Diagnostics

Why Thermedical’s Durablate catheter could address difficult-to-reach heart arrhythmias

Thermedical names nine experts to oversee pivotal SERF ablation testing after promising early results. Safety and six-month recurrence remain key tests.

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